Table 3.

Quality control tests for the final leptospirosis vaccines used in China.

Test	Specification
Identity	The microscopic agglutination test shall be performed on the final product using serogroup reference sera, and specific agglutination shall be observed.
Physical inspection	The product is a slightly opalescent liquid free of abnormal odor, foreign matter, or clumps not dispersed on shaking.
pH	6.4–7.4
Sodium chloride content	7.5–9.5 g/L
Phenol content	Not more than 3.0 g/L
Potency	The final product is diluted with physiological saline to 5 × 107 organisms/mL, and tested by the immunogenicity test described in Table 1.
Sterility	Sterile
Abnormal toxicity	Immunized animals should gain weight and survive without abnormality.